Whereas specificity is the percentage of true negatives without disease, and is useful for ruling in a positive test (if high specificity) but not necessarily ruling out a disease. A highly sensitive test is useful for ruling out a disease with a negative test but not necessarily ruling in the disease. Sensitivity is the percentage of true positives with the disease. Prior to further discussion of classification and diagnostic criteria, review of certain statistical principles is necessary to clarify differences between classification and diagnostic criteria. This article will help define both classification and diagnostic criteria, describe limitations of current classification criteria and how their use in clinical practice, while not sufficient alone for diagnosis, can be an aid or aide-mémoire in making a diagnosis.
While designed for clinical research, classification criteria are used and abused for clinical practice in patient care. This diagnostic uncertainty has led to the development of multiple sets of disease classification criteria for use in research on disease characterization, epidemiology, prognosis, and designing clinical trials for therapeutic investigation ( 3). Despite making significant technological advances with diagnostic tests such as anti-cyclic citrullinated peptides (CCP), diagnosis is still imperfect given lack of 100% specificity for rheumatoid arthritis, and even worse sensitivity ( 2). As opposed to a positive blood culture in infectious disease suggestive of bacteremia or a fasting blood glucose in endocrinology suggestive of diabetes mellitus, even the most common and well-studied clinical conditions in rheumatology such as rheumatoid arthritis can have significant diagnostic uncertainty of so-called “sero-negativity” up to 30% of the time ( 1). While understanding of the pathophysiology in each disease has advanced, single laboratory tests with high sensitivity and specificity sufficient to make a diagnosis, still do not exist for most of the rheumatic diseases. Multisystem clinical syndromes and diseases in Rheumatology attract clinicians and researchers whom seek to unify different shades of “gray” into a single diagnosis or classification criteria.
#RHEUMATOID ARTHRITIS DIAGNOSIS CRITERIA 2015 FULL#
Rheumatology is not a field of black and white, but a specialty full of gray.
We present the limits of current classification criteria, describe their use and abuse in clinical practice, and how they should be used with caution when applied in clinics. Despite these shortcomings, the clinician can still use classification criteria for understanding the disease as well as a guide for diagnosis with a few caveats.
Diagnostic criteria development is challenging primarily due to difficulty for universal application given significant differences in prevalence of rheumatic diseases based on geographical area and clinic settings. Classification criteria are being revised with improved methodology and further understanding of disease pathophysiology, but still may not encompass all unique clinical situations to be applied for diagnosis of heterogeneous, rare, evolving rheumatic diseases. Although, they are commonly used in clinical practice, their use may not be appropriate for routine diagnostic clinical care. In rheumatic diseases, classification criteria have been developed to identify well-defined homogenous cohorts for clinical research.
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